iPad for recording raw data
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We are discussing the possibility of using ipads for raw data capture in areas where we are not permitted to remove materials for biosecurity reasons. This would mean that the data would be recorded directly on the ipad which would remain in the secured areas and the data would be transferred wirelessly to either a printer or a cloud based storage folder. Is this acceptable for GLP and what would we need to do to validate the system?
The definition of the original record is required particularly for GLP. The printer option is a risk because it represents a paper/electronic hybrid that also requires paper archival.
A local data capture application on an internal server would be more secure than a print-out or cloud server, and could hold the designated “original” records. You would need to decide how long to retain the data on the iPads using a documented risk assessment. You could also consider industrial standard clean-room terminals for reasons of improved hygiene and connectivity.
As always you will need to document your requirements and formally test against them.
Your proposed solution is analogous to an electronic data capture (EDC) system as used in clinical trials, so you will find validation concepts if you search for this.
RQA GLP Committee
Dear Anon, with thanks to Chris for the very comprehensive answer, the GLP Committee can only add that any validation should be conducted as a routine GLP Study, with a plan of what you intend to do, the equipment and tests involved and a report written to document the results.